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Administration of Intravenous NRX100 (Ketamine) vs Placebo Infusion for Rapid Stabilization of Acute Suicidal Ideation and Behavior in Patients With Bipolar Depression

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Trial Profile

Administration of Intravenous NRX100 (Ketamine) vs Placebo Infusion for Rapid Stabilization of Acute Suicidal Ideation and Behavior in Patients With Bipolar Depression

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 01 Aug 2024

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At a glance

  • Drugs Ketamine (Primary) ; Cycloserine/lurasidone
  • Indications Bipolar depression; Suicidal ideation
  • Focus Registrational; Therapeutic Use
  • Acronyms SevereBD
  • Sponsors NeuroRX; NRx Pharmaceuticals

    • Most Recent Events

    • 29 Jul 2024 According to a NRx Pharmaceuticals media release, NRx remains on track to file the NDA for NRX-100 in Q4 2024 with anticipated PDUFA date in Q2 2025.
    • 08 Apr 2024 According to a NRx Pharmaceuticals media release, the Company has also announced plans to submit a New Drug Application to FDA this quarter for the use of ketamine as a short-term therapy for suicidal bipolar depression.
    • 28 Mar 2024 According to a NRx Pharmaceuticals media release, the company anticipates filing of New Drug Application for treatment of Acute Suicidality by June 2024 upon completion of required 9 month stability and CMC with anticipated 2024 PDUFA date.

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